MAUDE Adverse Event Report: MAKO Surgical Corp. CHECKPOINT 3.5 HEX IMPACTION STERILE; Orthopedic Stereotaxic Instrument

Catalog Number	111653
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The following was reported "while removing the checkpoint from the patient's pelvis, the checkpoint broke, leaving the tip inside the patient's body.".

• Brand Name: CHECKPOINT 3.5 HEX IMPACTION STERILE
• Common Device Name: Orthopedic Stereotaxic Instrument
• Manufacturer (Section D): MAKO Surgical Corp.; 3365 enterprise ave; weston FL 33331
• Manufacturer (Section G): MAKO Surgical Corp.; 3365 enterprise ave; weston FL 33331
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; +353()61498200
• MDR Report Key: 50791874
• Report Number: 3005985723-2026-00488
• Device Sequence Number: 21224992
• Product Code: OLO
• UDI-Device Identifier: 00848486017316
• UDI-Public: 00848486017316
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K112507
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 111653
• Device Lot Number: 29196700-004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown